You are on page 1of 53

Republic of the Philippines

Supreme Court
Manila

EN BANC

PHARMACEUTICAL and HEALTH G.R. NO. 173034


CARE ASSOCIATION of the
PHILIPPINES,
Petitioner,
Present:

PUNO, C.J.
QUISUMBING,
YNARES-SANTIAGO,
SANDOVAL-GUTIERREZ,
CARPIO,
- versus - AUSTRIA-MARTINEZ,
CORONA,
CARPIO-MORALES,
AZCUNA,
TINGA,
CHICO-NAZARIO,
GARCIA,
VELASCO, JR.,
NACHURA, and
REYES, JJ.
HEALTH SECRETARY
FRANCISCO T. DUQUE III;
HEALTH UNDERSECRETARIES
DR. ETHELYN P. NIETO,
DR. MARGARITA M. GALON,
ATTY. ALEXANDER A. PADILLA,
& DR. JADE F. DEL MUNDO; and
ASSISTANT SECRETARIES
DR. MARIO C. VILLAVERDE,
DR. DAVID J. LOZADA, AND
DR. NEMESIO T. GAKO, Promulgated:
Respondents. October 9, 2007
x- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - x
DECISION

AUSTRIA-MARTINEZ, J.:

The Court and all parties involved are in agreement that the best nourishment for an infant is
mother's milk. There is nothing greater than for a mother to nurture her beloved child straight
from her bosom. The ideal is, of course, for each and every Filipino child to enjoy the unequaled
benefits of breastmilk. But how should this end be attained?
Before the Court is a petition for certiorari under Rule 65 of the Rules of Court, seeking to
nullify Administrative Order (A.O.) No. 2006-0012 entitled, Revised Implementing Rules and
Regulations of Executive Order No. 51, Otherwise Known as The Milk Code, Relevant
International Agreements, Penalizing Violations Thereof, and for Other
Purposes(RIRR). Petitioner posits that the RIRR is not valid as it contains provisions that are not
constitutional and go beyond the law it is supposed to implement.

Named as respondents are the Health Secretary, Undersecretaries, and Assistant Secretaries of
the Department of Health (DOH). For purposes of herein petition, the DOH is
deemed impleaded as a co-respondent since respondents issued the questioned RIRR in their
capacity as officials of said executive agency.[1]

Executive Order No. 51 (Milk Code) was issued by President Corazon Aquino on October 28,
1986 by virtue of the legislative powers granted to the president under the Freedom
Constitution. One of the preambular clauses of the Milk Code states that the law seeks to give
effect to Article 11[2] of the International Code of Marketing of BreastmilkSubstitutes (ICMBS),
a code adopted by the World Health Assembly (WHA) in 1981. From 1982 to 2006, the WHA
adopted several Resolutions to the effect that breastfeeding should be supported, promoted and
protected, hence, it should be ensured that nutrition and health claims are not permitted
for breastmilk substitutes.
In 1990, the Philippines ratified the International Convention on the Rights of the Child. Article
24 of said instrument provides that State Parties should take appropriate measures to diminish
infant and child mortality, and ensure that all segments of society, specially parents and children,
are informed of the advantages of breastfeeding.

On May 15, 2006, the DOH issued herein assailed RIRR which was to take effect on July 7,
2006.

However, on June 28, 2006, petitioner, representing its members that are manufacturers
of breastmilk substitutes, filed the present Petition for Certiorari and Prohibition with Prayer for
the Issuance of a Temporary Restraining Order (TRO) or Writ of Preliminary Injunction.
The main issue raised in the petition is whether respondents officers of the DOH acted without or
in excess of jurisdiction, or with grave abuse of discretion amounting to lack or excess of
jurisdiction, and in violation of the provisions of the Constitution in promulgating the RIRR.[3]

On August 15, 2006, the Court issued a Resolution granting a TRO enjoining respondents from
implementing the questioned RIRR.
After the Comment and Reply had been filed, the Court set the case for oral arguments on June
19, 2007. The Court issued an Advisory (Guidance for Oral Arguments) dated June 5, 2007, to
wit:

The Court hereby sets the following issues:

1. Whether or not petitioner is a real party-in-interest;

2. Whether Administrative Order No. 2006-0012 or the Revised


Implementing Rules and Regulations (RIRR) issued by the Department of
Health (DOH) is not constitutional;
2.1 Whether the RIRR is in accord with the provisions of Executive Order No. 51
(Milk Code);

2.2 Whether pertinent international agreements1 entered into by


the Philippines are part of the law of the land and may be implemented by
the DOH through the RIRR; If in the affirmative, whether the RIRR is in
accord with the international agreements;

2.3 Whether Sections 4, 5(w), 22, 32, 47, and 52 of the RIRR violate the due
process clause and are in restraint of trade; and
2.4 Whether Section 13 of the RIRR on Total Effect provides sufficient
standards.
_____________
1 (1) United Nations Convention on the Rights of the Child; (2) the WHO
and Unicef 2002 Global Strategy on Infant and Young Child
Feeding; and (3) various World Health Assembly (WHA) Resolutions.
The parties filed their respective memoranda.

The petition is partly imbued with merit.

On the issue of petitioner's standing

With regard to the issue of whether petitioner may prosecute this case as the real party-in-
interest, the Court adopts the view enunciated in Executive Secretary v. Court of Appeals,[4] to
wit:
The modern view is that an association has standing to complain of injuries to its
members. This view fuses the legal identity of an association with that of its
members. An association has standing to file suit for its workers despite its
lack of direct interest if its members are affected by the action. An
organization has standing to assert the concerns of its constituents.

xxxx

x x x We note that, under its Articles of Incorporation, the respondent was


organized x x x to act as the representative of any individual, company, entity or
association on matters related to the manpower recruitment industry, and to
perform other acts and activities necessary to accomplish the purposes embodied
therein. The respondent is, thus, the appropriate party to assert the rights of
its members, because it and its members are in every practical sense
identical. x x x The respondent [association] is but the medium through
which its individual members seek to make more effective the expression of
their voices and the redress of their grievances. [5] (Emphasis supplied)

which was reasserted in Purok Bagong Silang Association, Inc. v. Yuipco,[6] where the Court
ruled that an association has the legal personality to represent its members because the results of
the case will affect their vital interests.[7]
Herein petitioner's Amended Articles of Incorporation contains a similar provision just like
in Executive Secretary, that the association is formed to represent directly or through approved
representatives the pharmaceutical and health care industry before the Philippine Government
and any of its agencies, the medical professions and the general public.[8] Thus, as an
organization, petitioner definitely has an interest in fulfilling its avowed purpose of representing
members who are part of the pharmaceutical and health care industry. Petitioner is duly
authorized[9] to take the appropriate course of action to bring to the attention of government
agencies and the courts any grievance suffered by its members which are directly affected by the
RIRR. Petitioner, which is mandated by its Amended Articles of Incorporation to represent the
entire industry, would be remiss in its duties if it fails to act on governmental action that would
affect any of its industry members, no matter how few or numerous they are. Hence, petitioner,
whose legal identity is deemed fused with its members, should be considered as a real party-in-
interest which stands to be benefited or injured by any judgment in the present action.

On the constitutionality of the provisions of the RIRR

First, the Court will determine if pertinent international instruments adverted to by respondents
are part of the law of the land.
Petitioner assails the RIRR for allegedly going beyond the provisions of the Milk Code, thereby
amending and expanding the coverage of said law. The defense of the DOH is that the RIRR
implements not only the Milk Code but also various international instruments[10] regarding infant
and young child nutrition. It is respondents' position that said international instruments are
deemed part of the law of the land and therefore the DOH may implement them through the
RIRR.
The Court notes that the following international instruments invoked by respondents, namely: (1)
The United Nations Convention on the Rights of the Child; (2) The International Covenant on
Economic, Social and Cultural Rights; and (3) the Convention on the Elimination of All Forms
of Discrimination Against Women, only provide in general terms that steps must be taken by
State Parties to diminish infant and child mortality and inform society of the advantages of
breastfeeding, ensure the health and well-being of families, and ensure that women are provided
with services and nutrition in connection with pregnancy and lactation. Said instruments do not
contain specific provisions regarding the use or marketing of breastmilk substitutes.
The international instruments that do have specific provisions regarding breastmilk substitutes
are the ICMBS and various WHA Resolutions.
Under the 1987 Constitution, international law can become part of the sphere of domestic law
either by transformation or incorporation.[11] The transformation method requires that an
international law be transformed into a domestic law through a constitutional mechanism such as
local legislation. The incorporation method applies when, by mere constitutional declaration,
international law is deemed to have the force of domestic law.[12]

Treaties become part of the law of the land through transformation pursuant to Article VII,
Section 21 of the Constitution which provides that [n]o treaty or international agreement shall be
valid and effective unless concurred in by at least two-thirds of all the members of the
Senate. Thus, treaties or conventional international law must go through a process prescribed by
the Constitution for it to be transformed into municipal law that can be applied to domestic
conflicts.[13]

The ICMBS and WHA Resolutions are not treaties as they have not been concurred in by at least
two-thirds of all members of the Senate as required under Section 21, Article VII of the 1987
Constitution.

However, the ICMBS which was adopted by the WHA in 1981 had been transformed into
domestic law through local legislation, the Milk Code. Consequently, it is the Milk Code that has
the force and effect of law in this jurisdiction and not the ICMBS per se.

The Milk Code is almost a verbatim reproduction of the ICMBS, but it is well to emphasize at
this point that the Code did not adopt the provision in the ICMBS absolutely prohibiting
advertising or other forms of promotion to the general public of products within the scope of the
ICMBS. Instead, the Milk Code expressly provides that advertising, promotion, or other
marketing materials may be allowed if such materials are duly authorized and approved by
the Inter-Agency Committee (IAC).

On the other hand, Section 2, Article II of the 1987 Constitution, to wit:

SECTION 2. The Philippines renounces war as an instrument of national


policy, adopts the generally accepted principles of international law as part of
the law of the land and adheres to the policy of peace, equality, justice, freedom,
cooperation and amity with all nations. (Emphasis supplied)

embodies the incorporation method.[14]

In Mijares v. Ranada,[15] the Court held thus:

[G]enerally accepted principles of international law, by virtue of the incorporation


clause of the Constitution, form part of the laws of the land even if they do not
derive from treaty obligations. The classical formulation in international law
sees those customary rules accepted as binding result from the combination
[of] two elements: the established, widespread, and consistent practice on the
part of States; and a psychological element known as
the opinion juris sive necessitates (opinion as to law or necessity). Implicit in the
latter element is a belief that the practice in question is rendered obligatory by
the existence of a rule of law requiring it.[16] (Emphasis supplied)
Generally accepted principles of international law refers to norms of general or customary
international law which are binding on all states,[17] i.e., renunciation of war as an instrument of
national policy, the principle of sovereign immunity,[18] a person's right to life, liberty and due
process,[19] and pacta sunt servanda,[20] among others. The concept ofgenerally accepted
principles of law has also been depicted in this wise:

Some legal scholars and judges look upon certain general principles of law as a
primary source of international law because they have the character of jus
rationale and are valid through all kinds of human societies. (Judge Tanaka in
his dissenting opinion in the 1966 South West Africa Case, 1966 I.C.J.
296). O'Connell holds that certain priniciples are part of international law
because they are basic to legal systems generally and hence part of
the jus gentium. These principles, he believes, are established by a process of
reasoning based on the common identity of all legal systems. If there should be
doubt or disagreement, one must look to state practice and determine whether the
municipal law principle provides a just and acceptable
[21]
solution. x x x (Emphasis supplied)

Fr. Joaquin G. Bernas defines customary international law as follows:

Custom or customary international law means a general and consistent practice of


states followed by them from a sense of legal obligation [opinio juris].
(Restatement) This statement contains the two basic elements of custom:
the material factor, thatis, how states behave, and the psychological
or subjective factor, that is, why they behave the way they do.

xxxx

The initial factor for determining the existence of custom is the actual behavior of
states. This includes several elements: duration, consistency, and generality of the
practice of states.

The required duration can be either short or long. x x x

xxxx

Duration therefore is not the most important element. More important is the
consistency and the generality of the practice. x x x

xxxx

Once the existence of state practice has been established, it becomes necessary to
determine why states behave the way they do.Do states behave the way they do
because they consider it obligatory to behave thus or do they do it only as a
matter of courtesy? Opinio juris, or the belief that a certain form of behavior
is obligatory, is what makes practice an international rule. Without it, practice
is not law.[22] (Underscoring and Emphasis supplied)

Clearly, customary international law is deemed incorporated into our domestic system.[23]

WHA Resolutions have not been embodied in any local legislation. Have they attained the status
of customary law and should they then be deemed incorporated as part of the law of the land?
The World Health Organization (WHO) is one of the international specialized agencies allied
with the United Nations (UN) by virtue of Article 57,[24] in relation to Article 63[25] of the UN
Charter. Under the 1946 WHO Constitution, it is the WHA which determines the policies of the
WHO,[26] and has the power to adopt regulations concerning advertising and labeling of
biological, pharmaceutical and similar products moving in international commerce,[27] and to
make recommendations to members with respect to any matter within the competence of the
Organization.[28] The legal effect of its regulations, as opposed to recommendations, is quite
different.

Regulations, along with conventions and agreements, duly adopted by the WHA bind member
states thus:

Article 19. The Health Assembly shall have authority to adopt conventions or
agreements with respect to any matter within the competence of the Organization.
A two-thirds vote of the Health Assembly shall be required for the adoption of
such conventions or agreements, which shall come into force for each
Member when accepted by it in accordance with its constitutional processes.

Article 20. Each Member undertakes that it will, within eighteen months after
the adoption by the Health Assembly of a convention or agreement, take action
relative to the acceptance of such convention or agreement. Each Member
shall notify the Director-General of the action taken, and if it does not accept such
convention or agreement within the time limit, it will furnish a statement of the
reasons for non-acceptance. In case of acceptance, each Member agrees to make
an annual report to the Director-General in accordance with Chapter XIV.

Article 21. The Health Assembly shall have authority to adopt regulations
concerning: (a) sanitary and quarantine requirements and other procedures
designed to prevent the international spread of disease; (b) nomenclatures with
respect to diseases, causes of death and public health practices; (c) standards with
respect to diagnostic procedures for international use; (d) standards with respect
to the safety, purity and potency of biological, pharmaceutical and similar
products moving in international commerce; (e) advertising and labeling of
biological, pharmaceutical and similar products moving in international
commerce.

Article 22. Regulations adopted pursuant to Article 21 shall come into force for
all Members after due notice has been given of their adoption by the Health
Assembly except for such Members as may notify the Director-General of
rejection or reservations within the period stated in the notice. (Emphasis
supplied)
On the other hand, under Article 23, recommendations of the WHA do not come into
force for members, in the same way that conventions or agreements under Article 19
and regulations under Article 21 come into force. Article 23 of the WHO Constitution reads:

Article 23. The Health Assembly shall have authority to make


recommendations to Members with respect to any matter within the competence
of the Organization. (Emphasis supplied)

The absence of a provision in Article 23 of any mechanism by which the recommendation would
come into force for member states is conspicuous.

The former Senior Legal Officer of WHO, Sami Shubber, stated that WHA recommendations are
generally not binding, but they carry moral and political weight, as they constitute the judgment
on a health issue of the collective membership of the highest international body in the field of
health.[29] Even the ICMBS itself was adopted as a mere recommendation, as WHA Resolution
No. 34.22 states:

The Thirty-Fourth World Health Assembly x x x adopts, in the sense of Article


23 of the Constitution, the International Code of Marketing
of Breastmilk Substitutes annexed to the present resolution. (Emphasis supplied)

The Introduction to the ICMBS also reads as follows:

In January 1981, the Executive Board of the World Health Organization at its
sixty-seventh session, considered the fourth draft of the code, endorsed it, and
unanimously recommended to the Thirty-fourth World Health Assembly the text
of a resolution by which it would adopt the code in the form of a
recommendation rather than a regulation. x x x (Emphasis supplied)

The legal value of WHA Resolutions as recommendations is summarized in Article 62 of the


WHO Constitution, to wit:

Art. 62. Each member shall report annually on the action taken with respect to
recommendations made to it by the Organization, and with respect to
conventions, agreements and regulations.
Apparently, the WHA Resolution adopting the ICMBS and subsequent WHA Resolutions urging
member states to implement the ICMBS are merely recommendatory and legally non-
binding. Thus, unlike what has been done with the ICMBS whereby the legislature enacted
most of the provisions into law which is the Milk Code, the subsequent WHA
Resolutions,[30] specifically providing for exclusive breastfeeding from 0-6 months,
continued breastfeeding up to 24 months, and absolutely prohibiting advertisements and
promotions of breastmilk substitutes, have not been adopted as a domestic law.

It is propounded that WHA Resolutions may constitute soft law or non-binding norms, principles
and practices that influence state behavior.[31]

Soft law does not fall into any of the categories of international law set forth in Article 38,
Chapter III of the 1946 Statute of the International Court of Justice.[32] It is, however, an
expression of non-binding norms, principles, and practices that influence state
[33]
behavior. Certain declarations and resolutions of the UN General Assembly fall under this
category.[34]The most notable is the UN Declaration of Human Rights, which this Court has
enforced in various cases, specifically,Government of Hongkong Special Administrative Region
v. Olalia,[35] Mejoff v. Director of Prisons,[36] Mijares v.Raada[37] and Shangri-la International
Hotel Management, Ltd. v. Developers Group of Companies, Inc..[38]

The World Intellectual Property Organization (WIPO), a specialized agency attached to the UN
with the mandate to promote and protect intellectual property worldwide, has resorted to soft law
as a rapid means of norm creation, in order to reflect and respond to the changing needs and
demands of its constituents.[39] Other international organizations which have resorted to soft law
include the International Labor Organization and the Food and Agriculture Organization (in the
form of the Codex Alimentarius).[40]

WHO has resorted to soft law. This was most evident at the time of the Severe Acute Respiratory
Syndrome (SARS) and Avian flu outbreaks.

Although the IHR Resolution does not create new international law binding on
WHO member states, it provides an excellent example of the power of "soft
law" in international relations. International lawyers typically distinguish
binding rules of international law-"hard law"-from non-binding norms,
principles, and practices that influence state behavior-"soft law." WHO has
during its existence generated many soft law norms, creating a "soft law
regime" in international governance for public health.

The "soft law" SARS and IHR Resolutions represent significant steps in laying
the political groundwork for improved international cooperation on infectious
diseases. These resolutions clearly define WHO member states' normative duty to
cooperate fully with other countries and with WHO in connection with infectious
disease surveillance and response to outbreaks.

This duty is neither binding nor enforceable, but, in the wake of the SARS
epidemic, the duty is powerful politically for two reasons. First, the SARS
outbreak has taught the lesson that participating in, and enhancing, international
cooperation on infectious disease controls is in a country's self-interest x x x if
this warning is heeded, the "soft law" in the SARS and IHR Resolution could
inform the development of general and consistent state practice on infectious
disease surveillance and outbreak response, perhaps crystallizing eventually into
customary international law on infectious disease prevention and control.[41]

In the Philippines, the executive department implemented certain measures recommended by


WHO to address the outbreaks of SARS and Avian flu by issuing Executive Order (E.O.) No.
201 on April 26, 2003 and E.O. No. 280 on February 2, 2004, delegating to various departments
broad powers to close down schools/establishments, conduct health surveillance and monitoring,
and ban importation of poultry and agricultural products.

It must be emphasized that even under such an international emergency, the duty of a state to
implement the IHR Resolution was still considered not binding or enforceable, although said
resolutions had great political influence.

As previously discussed, for an international rule to be considered as customary law, it must be


established that such rule is being followed by states because they consider it obligatory to
comply with such rules (opinio juris). Respondents have not presented any evidence to prove
that the WHA Resolutions, although signed by most of the member states, were in fact enforced
or practiced by at least a majority of the member states; neither have respondents proven that any
compliance by member states with said WHA Resolutions was obligatory in nature.
Respondents failed to establish that the provisions of pertinent WHA Resolutions are customary
international law that may be deemed part of the law of the land.

Consequently, legislation is necessary to transform the provisions of the WHA Resolutions into
domestic law. The provisions of the WHA Resolutions cannot be considered as part of the
law of the land that can be implemented by executive agencies without the need of a law
enacted by the legislature.

Second, the Court will determine whether the DOH may implement the provisions of the WHA
Resolutions by virtue of its powers and functions under the Revised Administrative Code even in
the absence of a domestic law.

Section 3, Chapter 1, Title IX of the Revised Administrative Code of 1987 provides that the
DOH shall define the national health policy and implement a national health plan within the
framework of the government's general policies and plans, and issue orders and regulations
concerning the implementation of established health policies.

It is crucial to ascertain whether the absolute prohibition on advertising and other forms of
promotion of breastmilksubstitutes provided in some WHA Resolutions has been adopted as part
of the national health policy.

Respondents submit that the national policy on infant and young child feeding is embodied in
A.O. No. 2005-0014, dated May 23, 2005. Basically, the Administrative Order declared the
following policy guidelines: (1) ideal breastfeeding practices, such as early initiation of
breastfeeding, exclusive breastfeeding for the first six months, extended breastfeeding up to two
years and beyond; (2) appropriate complementary feeding, which is to start at age six months; (3)
micronutrient supplementation; (4) universal salt iodization; (5) the exercise of other feeding
options; and (6) feeding in exceptionally difficult circumstances. Indeed, the primacy of
breastfeeding for children is emphasized as a national health policy.However, nowhere in A.O.
No. 2005-0014 is it declared that as part of such health policy, the advertisement or
promotion of breastmilk substitutes should be absolutely prohibited.
The national policy of protection, promotion and support of breastfeeding cannot automatically
be equated with a total ban on advertising for breastmilk substitutes.
In view of the enactment of the Milk Code which does not contain a total ban on the advertising
and promotion of breastmilk substitutes, but instead, specifically creates an IAC which will
regulate said advertising and promotion, it follows that a total ban policy could be implemented
only pursuant to a law amending the Milk Code passed by the constitutionally authorized
branch of government, the legislature.

Thus, only the provisions of the Milk Code, but not those of subsequent WHA
Resolutions, can be validly implemented by the DOH through the subject RIRR.

Third, the Court will now determine whether the provisions of the RIRR are in accordance with
those of the Milk Code.

In support of its claim that the RIRR is inconsistent with the Milk Code, petitioner alleges the
following:

1. The Milk Code limits its coverage to children 0-12 months old, but the RIRR
extended its coverage to young children or those from ages two years old and beyond:

MILK CODE RIRR


WHEREAS, in order to ensure that safe Section 2. Purpose These Revised Rules and
and adequate nutrition for infants is Regulations are hereby promulgated to ensure
provided, there is a need to protect and the provision of safe and adequate nutrition for
promote breastfeeding and to inform the infants and young children by the promotion,
public about the proper use protection and support of breastfeeding and by
of breastmilk substitutes and supplements ensuring the proper use
and related products through adequate, of breastmilk substitutes, breastmilksupplements
consistent and objective information and and related products when these are medically
appropriate regulation of the marketing and indicated and only when necessary, on the basis
distribution of the said substitutes, of adequate information and through appropriate
supplements and related products; marketing and distribution.

SECTION 4(e). Infant means a person Section 5(ff). Young Child means a person from
falling within the age bracket of 0-12 the age of more than twelve (12) months up to
months. the age of three (3) years (36 months).
2. The Milk Code recognizes that infant formula may be a proper and possible
substitute for breastmilk in certain instances; but the RIRR provides exclusive
breastfeeding for infants from 0-6 months and declares that there is no substitute nor
replacement for breastmilk:

MILK CODE RIRR


WHEREAS, in order to ensure that safe Section 4. Declaration of Principles The
and adequate nutrition for infants is following are the underlying principles
provided, there is a need to protect and from which the revised rules and
promote breastfeeding and to inform the regulations are premised upon:
public about the proper use
of breastmilk substitutes and supplements a. Exclusive breastfeeding is for
and related products through adequate, infants from 0 to six (6) months.
consistent and objective information and
appropriate regulation of the marketing and b. There is no substitute or
distribution of the said substitutes, replacement for breastmilk.
supplements and related products;

3. The Milk Code only regulates and does not impose unreasonable requirements for
advertising and promotion; RIRR imposes an absolute ban on such activities
for breastmilk substitutes intended for infants from 0-24 months old or beyond, and
forbids the use of health and nutritional claims. Section 13 of the RIRR, which
provides for a total effect in the promotion of products within the scope of the Code, is
vague:

MILK CODE RIRR


SECTION 6. The General Public and Section 4. Declaration of Principles The
Mothers. following are the underlying principles
(a) No advertising, promotion or other from which the revised rules and
marketing materials, whether written, audio regulations are premised upon:
or visual, for products within the scope of
this Code shall be printed, published, xxxx
distributed, exhibited and broadcast unless
such materials are duly authorized and f. Advertising, promotions, or sponsor-
approved by an inter-agency ships of infant
committee created herein pursuant to the formula, breastmilk substitutes and other
applicable standards provided for in this related products are prohibited.
Code.
Section 11. Prohibition No advertising,
promotions, sponsorships, or marketing
materials and
activities for breastmilksubstitutes
intended for infants and young children up
to twenty-four (24) months, shall be
allowed, because they tend to convey or
give subliminal messages or impressions
that undermine breastmilk and
breastfeeding or otherwise
exaggerate breastmilk substitutes and/or
replacements, as well as related products
covered within the scope of this Code.

Section 13. Total Effect - Promotion of


products within the scope of this Code must
be objective and should not equate or make
the product appear to be as good or equal
to breastmilk or breastfeeding in the
advertising concept. It must not in any case
undermine breastmilk or breastfeeding. The
total effect should not directly or indirectly
suggest that buying their product would
produce better individuals, or resulting in
greater love, intelligence, ability, harmony
or in any manner bring better health to the
baby or other such exaggerated and
unsubstantiated claim.

Section 15. Content of Materials. - The


following shall not be included in
advertising, promotional and marketing
materials:

a. Texts, pictures, illustrations or


information which discourage or tend to
undermine the benefits or superiority of
breastfeeding or which idealize the use
of breastmilksubstitutes and milk
supplements. In this connection, no pictures
of babies and children together with their
mothers, fathers, siblings, grandparents,
other relatives or caregivers (or yayas) shall
be used in any advertisements for infant
formula and breastmilk supplements;
b. The term humanized, maternalized, close
to mother's milk or similar words in
describing breastmilk substitutes or milk
supplements;

c. Pictures or texts that idealize the use of


infant and milk formula.

Section 16. All health and nutrition claims


for products within the scope of the Code
are absolutely prohibited. For this purpose,
any phrase or words that connotes to
increase emotional, intellectual abilities of
the infant and young child and other like
phrases shall not be allowed.

4. The RIRR imposes additional labeling requirements not found in the Milk Code:

MILK CODE RIRR


SECTION 10. Containers/Label. Section 26. Content Each container/label
(a) Containers and/or labels shall be shall contain such message, in both Filipino
designed to provide the necessary and English languages, and which message
information about the appropriate cannot be readily separated therefrom,
use of the products, and in such a relative the following points:
way as not to discourage (a) The words or phrase Important Notice
breastfeeding. or Government Warning or their
(b) Each container shall have a clear, equivalent;
conspicuous and easily readable (b) A statement of the superiority of
and understandable message in breastfeeding;
Pilipino or English printed on it, or (c) A statement that there is no substitute
on a label, which message can not for breastmilk;
readily become separated from it, (d) A statement that the product shall be
and which shall include the used only on the advice of a health
following points: worker as to the need for its use and
(i) the words Important the proper methods of use;
Notice or their equivalent; (e) Instructions for appropriate prepara-tion,
(ii) a statement of the and a warning against the health
superiority of breastfeeding; hazards of inappropriate
(iii) a statement that the product preparation;and
shall be used only on the advice (f) The health hazards of unnecessary or
of a health worker as to the improper use of infant formula and
need for its use and the proper other related products including
methods of use;and information that powdered infant
(iv) instructions for appropriate formula may contain pathogenic
preparation, and a warning microorganisms and must be
against the health hazards of prepared and used appropriately.
inappropriate preparation.

5. The Milk Code allows dissemination of information on infant formula to health


professionals; the RIRR totally prohibits such activity:

MILK CODE RIRR


SECTION 7. Health Care System. Section 22. No manufacturer, distributor,
(b) No facility of the health care system or representatives of products covered by
shall be used for the purpose of promoting the Code shall be allowed to conduct or be
infant formula or other products within the involved in any activity on breastfeeding
scope of this Code. This Code does not, promotion, education and production of
however, preclude the dissemination of Information, Education and
information to health professionals as Communication (IEC) materials on
provided in Section 8(b). breastfeeding, holding of or participating as
speakers in classes or seminars for women
SECTION 8. Health Workers. - and children activities and to avoid the use
(b) Information provided by manufacturers of these venues to market their brands or
and distributors to health professionals company names.
regarding products within the scope of this
Code shall be restricted to scientific and SECTION 16. All health and nutrition
factual matters and such information shall claims for products within the scope of the
not imply or create a belief that bottle- Code are absolutely prohibited. For this
feeding is equivalent or superior to purpose, any phrase or words that
breastfeeding. It shall also include the connotes to increase emotional, intellectual
information specified in Section 5(b). abilities of the infant and young child and
other like phrases shall not be allowed.

6. The Milk Code permits milk manufacturers and distributors to extend assistance in
research and continuing education of health professionals; RIRR absolutely forbids the
same.

MILK CODE RIRR


SECTION 8. Health Workers Section 4. Declaration of Principles
(e) Manufacturers and distributors of The following are the underlying principles
products within the scope of this Code may from which the revised rules and
assist in the research, scholarships and regulations are premised upon:
continuing education, of health i. Milk companies, and their
professionals,in accordance with the rules representatives, should not form
and regulations promulgated by the part of any policymaking body or
Ministry of Health. entity in relation to the
advancement of breasfeeding.
SECTION 22. No manufacturer,
distributor, or representatives of products
covered by the Code shall be allowed to
conduct or be involved in any activity on
breastfeeding promotion, education and
production of Information, Education and
Communication (IEC) materials on
breastfeeding, holding of or participating as
speakers in classes or seminars for women
and children activitiesand to avoid the use
of these venues to market their brands or
company names.

SECTION 32. Primary Responsibility of


Health Workers - It is the primary
responsibility of the health workers to
promote, protect and support breastfeeding
and appropriate infant and young child
feeding. Part of this responsibility is to
continuously update their knowledge and
skills on breastfeeding. No assistance,
support, logistics or training from milk
companies shall be permitted.

7. The Milk Code regulates the giving of donations; RIRR absolutely prohibits it.

MILK CODE RIRR


SECTION 6. The General Public and Section 51. Donations Within the Scope
Mothers. of This Code - Donations of products,
(f) Nothing herein contained shall prevent materials, defined and covered under the
donations from manufacturers and Milk Code and these implementing rules
distributors of products within the scope of and regulations, shall be strictly prohibited.
this Code upon request by or with the
approval of the Ministry of Health. Section 52. Other Donations By Milk
Companies Not Covered by this Code. -
Donations of products, equipments, and the
like, not otherwise falling within the scope
of this Code or these Rules, given by milk
companies and their agents, representatives,
whether in kind or in cash, may only be
coursed through the Inter Agency
Committee (IAC), which shall determine
whether such donation be accepted or
otherwise.
8. The RIRR provides for administrative sanctions not imposed by the Milk Code.

MILK CODE RIRR


Section 46. Administrative
Sanctions. The following administrative
sanctions shall be imposed upon any
person, juridical or natural, found to have
violated the provisions of the Code and its
implementing Rules and Regulations:
a) 1st violation Warning;
b) 2nd violation Administrative fine of a
minimum of Ten Thousand
(P10,000.00) to Fifty Thousand
(P50,000.00) Pesos, depending on
the gravity and extent of the
violation, including the recall of the
offending product;
c) 3rd violation Administrative Fine of a
minimum of Sixty Thousand
(P60,000.00) to One Hundred Fifty
Thousand (P150,000.00) Pesos,
depending on the gravity and extent
of the violation, and in addition
thereto, the recall of the offending
product, and suspension of the
Certificate of Product Registration
(CPR);
th
d) 4 violation Administrative Fine of a
minimum of Two Hundred Thousand
(P200,000.00) to Five Hundred
(P500,000.00) Thousand Pesos,
depending on the gravity and extent
of the violation; and in addition
thereto, the recall of the product,
revocation of the CPR, suspension of
the License to Operate (LTO) for
one year;
e) 5th and succeeding repeated violations
Administrative Fine of One Million
(P1,000,000.00) Pesos, the recall of
the offending product, cancellation of
the CPR, revocation of the License to
Operate (LTO) of the company
concerned, including the blacklisting
of the company to be furnished the
Department of Budget and
Management (DBM) and the
Department of Trade and Industry
(DTI);
f) An additional penalty of Two Thou-sand
Five Hundred (P2,500.00) Pesos per
day shall be made for every day the
violation continues after having
received the order from the IAC or
other such appropriate body,
notifying and penalizing the
company for the infraction.
For purposes of determining whether or not
there is repeated violation, each product
violation belonging or owned by a
company, including those of their
subsidiaries, are deemed to be violations of
the concerned milk company and shall not
be based on the specific violating product
alone.

9. The RIRR provides for repeal of existing laws to the contrary.

The Court shall resolve the merits of the allegations of petitioner seriatim.

1. Petitioner is mistaken in its claim that the Milk Code's coverage is limited
only to children 0-12 months old.Section 3 of the Milk Code states:

SECTION 3. Scope of the Code The Code applies to the marketing, and practices
related thereto, of the following products: breastmilk substitutes, including infant
formula; other milk products, foods and beverages, including bottle-fed
complementary foods, when marketed or otherwise represented to be suitable,
with or without modification, for use as a partial or total replacement
of breastmilk; feeding bottles and teats. It also applies to their quality and
availability, and to information concerning their use.
Clearly, the coverage of the Milk Code is not dependent on the age of the child but on the kind
of product being marketed to the public. The law treats infant formula, bottle-fed
complementary food, and breastmilk substitute as separate and distinct product categories.

Section 4(h) of the Milk Code defines infant formula as a breastmilk substitute x x x to
satisfy the normal nutritional requirements of infants up to between four to six months of age,
and adapted to their physiological characteristics; while under Section 4(b), bottle-fed
complementary food refers to any food, whether manufactured or locally prepared, suitable as a
complement to breastmilk or infant formula, when either becomes insufficient to satisfy the
nutritional requirements of the infant. An infant under Section 4(e) is a person falling within the
age bracket 0-12 months. It is the nourishment of this group of infants or children aged 0-12
months that is sought to be promoted and protected by the Milk Code.

But there is another target group. Breastmilk substitute is defined under Section 4(a)
as any food being marketed or otherwise presented as a partial or total replacement for
breastmilk, whether or not suitable for that purpose. This section conspicuously lacks reference
to any particular age-group of children. Hence, the provision of the Milk Code cannot be
considered exclusive for children aged 0-12 months. In other words, breastmilk substitutes
may also be intended for young children more than 12 months of age. Therefore, by regulating
breastmilk substitutes, the Milk Code also intends to protect and promote the nourishment
of children more than 12 months old.

Evidently, as long as what is being marketed falls within the scope of the Milk Code as
provided in Section 3, then it can be subject to regulation pursuant to said law, even if the
product is to be used by children aged over 12 months.

There is, therefore, nothing objectionable with Sections 2[42] and 5(ff)[43] of the RIRR.

2. It is also incorrect for petitioner to say that the RIRR, unlike the Milk Code,
does not recognize that breastmilk substitutes may be a proper and possible substitute
for breastmilk.
The entirety of the RIRR, not merely truncated portions thereof, must
[44]
be considered and construed together. As held in De Luna v. Pascual, [t]he particular words,
clauses and phrases in the Rule should not be studied as detached and isolated expressions, but
the whole and every part thereof must be considered in fixing the meaning of any of its parts and
in order to produce a harmonious whole.
Section 7 of the RIRR provides that when medically indicated and only when
necessary, the use of breastmilksubstitutes is proper if based on complete and updated
information. Section 8 of the RIRR also states that information and educational materials should
include information on the proper use of infant formula when the use thereof is needed.

Hence, the RIRR, just like the Milk Code, also recognizes that in certain cases, the
use of breastmilksubstitutes may be proper.

3. The Court shall ascertain the merits of allegations 3[45] and 4[46] together as
they are interlinked with each other.

To resolve the question of whether the labeling requirements and advertising regulations under
the RIRR are valid, it is important to deal first with the nature, purpose, and depth of the
regulatory powers of the DOH, as defined in general under the 1987 Administrative Code,[47] and
as delegated in particular under the Milk Code.

Health is a legitimate subject matter for regulation by the DOH (and certain other
administrative agencies) in exercise of police powers delegated to it. The sheer span of
jurisprudence on that matter precludes the need to further discuss it..[48] However, health
information, particularly advertising materials on apparently non-toxic products
like breastmilk substitutes and supplements, is a relatively new area for regulation by the
DOH.[49]
As early as the 1917 Revised Administrative Code of the Philippine Islands,[50] health
information was already within the ambit of the regulatory powers of the predecessor of
DOH.[51] Section 938 thereof charged it with the duty to protect the health of the people, and
vested it with such powers as (g) the dissemination of hygienic information among the people
and especially the inculcation of knowledge as to the proper care of infants and the methods of
preventing and combating dangerous communicable diseases.

Seventy years later, the 1987 Administrative Code tasked respondent DOH to carry out
the state policy pronounced under Section 15, Article II of the 1987 Constitution, which is to
protect and promote the right to health of the people and instill health consciousness among
them.[52] To that end, it was granted under Section 3 of the Administrative Code the power to
(6) propagate health information and educate the population on important health, medical and
environmental matters which have health implications.[53]

When it comes to information regarding nutrition of infants and young children,


however, the Milk Code specifically delegated to the Ministry of Health (hereinafter referred to
as DOH) the power to ensure that there is adequate, consistent and objective information on
breastfeeding and use of breastmilk substitutes, supplements and related products; and the power
to control such information. These are expressly provided for in Sections 12 and 5(a), to wit:

SECTION 12. Implementation and Monitoring


xxxx

(b) The Ministry of Health shall be principally responsible for the


implementation and enforcement of the provisions of this Code. For this
purpose, the Ministry of Health shall have the following powers and
functions:

(1) To promulgate such rules and regulations as are


necessary or proper for the implementation of this Code
and the accomplishment of its purposes and objectives.

xxxx

(4) To exercise such other powers and functions as may be


necessary for or incidental to the attainment of the purposes
and objectives of this Code.

SECTION 5. Information and Education

(a) The government shall ensure that objective and consistent information is
provided on infant feeding, for use by families and those involved in the field of
infant nutrition. This responsibility shall cover the planning, provision, design and
dissemination of information, and the control thereof, on infant
nutrition. (Emphasis supplied)

Further, DOH is authorized by the Milk Code to control the content of any information
on breastmilk vis--vis breastmilksubstitutes, supplement and related products, in the following
manner:
SECTION 5. x x x

(b) Informational and educational materials, whether written, audio, or visual,


dealing with the feeding of infants and intended to reach pregnant women
and mothers of infants, shall include clear information on all the following
points: (1) the benefits and superiority of breastfeeding; (2) maternal
nutrition, and the preparation for and maintenance of breastfeeding; (3)
the negative effect on breastfeeding of introducing partial bottlefeeding;
(4) the difficulty of reversing the decision not to breastfeed; and (5) where
needed, the proper use of infant formula, whether manufactured
industrially or home-prepared. When such materials contain information
about the use of infant formula, they shall include the social and
financial implications of its use; the health hazards of inappropriate
foods or feeding methods; and, in particular, the health hazards of
unnecessary or improper use of infant formula and
other breastmilk substitutes. Such materials shall not use any picture or
text which may idealize the use of breastmilk substitutes.

SECTION 8. Health Workers

xxxx
(b) Information provided by manufacturers and distributors to health professionals
regarding products within the scope of this Code shall be restricted to
scientific and factual matters, and such information shall not imply or
create a belief that bottlefeeding is equivalent or superior to
breastfeeding. It shall also include the information specified in Section
5(b).

SECTION 10. Containers/Label

(a) Containers and/or labels shall be designed to provide the necessary


information about the appropriate use of the products, andin such a way as not to
discourage breastfeeding.

xxxx
(d) The term humanized, maternalized or similar terms shall not be
used. (Emphasis supplied)

The DOH is also authorized to control the purpose of the information and to whom such
information may be disseminated under Sections 6 through 9 of the Milk Code[54] to ensure that
the information that would reach pregnant women, mothers of infants, and health professionals
and workers in the health care system is restricted to scientific and factual matters and
shall not imply or create a belief that bottlefeeding is equivalent or superior to breastfeeding.

It bears emphasis, however, that the DOH's power under the Milk Code
to control information regarding breastmilkvis-a-vis breastmilk substitutes is not absolute as the
power to control does not encompass the power to absolutely prohibit the advertising, marketing,
and promotion of breastmilk substitutes.

The following are the provisions of the Milk Code that unequivocally indicate that the
control over information given to the DOH is not absolute and that absolute prohibition is not
contemplated by the Code:

a) Section 2 which requires adequate information and appropriate marketing and


distribution of breastmilksubstitutes, to wit:

SECTION 2. Aim of the Code The aim of the Code is to contribute to the
provision of safe and adequate nutrition for infants by the protection and
promotion of breastfeeding and by ensuring the proper use
of breastmilk substitutes and breastmilksupplements when these are necessary, on
the basis of adequate information and through appropriate marketing and
distribution.

b) Section 3 which specifically states that the Code applies to the marketing of and
practices related to breastmilksubstitutes, including infant formula, and to information
concerning their use;
c) Section 5(a) which provides that the government shall ensure that objective and
consistent information is provided on infant feeding;

d) Section 5(b) which provides that written, audio or visual informational and educational
materials shall not use any picture or text which may idealize the use of breastmilk substitutes
and should include information on the health hazards of unnecessary or improper use of said
product;
e) Section 6(a) in relation to Section 12(a) which creates and empowers the IAC to
review and examine advertising, promotion, and other marketing materials;

f) Section 8(b) which states that milk companies may provide information to health
professionals but such information should be restricted to factual and scientific matters and shall
not imply or create a belief that bottlefeeding is equivalent or superior to breastfeeding; and

g) Section 10 which provides that containers or labels should not contain information that
would discourage breastfeeding and idealize the use of infant formula.

It is in this context that the Court now examines the assailed provisions of the RIRR
regarding labeling and advertising.

Sections 13[55] on total effect and 26[56] of Rule VII of the RIRR contain some labeling
requirements, specifically: a) that there be a statement that there is no substitute to breastmilk;
and b) that there be a statement that powdered infant formula may contain pathogenic
microorganisms and must be prepared and used appropriately. Section 16[57] of the RIRR
prohibits all health and nutrition claims for products within the scope of the Milk Code, such as
claims of increased emotional and intellectual abilities of the infant and young child.

These requirements and limitations are consistent with the provisions of Section 8 of the
Milk Code, to wit:

SECTION 8. Health workers -


xxxx
(b) Information provided by manufacturers and distributors to health
professionals regarding products within the scope of thisCode shall be restricted
to scientific and factual matters, and such information shall not imply or create
a belief thatbottlefeeding is equivalent or superior to breastfeeding. It shall also
include the information specified in Section 5.[58](Emphasis supplied)

and Section 10(d)[59] which bars the use on containers and labels of the terms humanized,
maternalized, or similar terms.

These provisions of the Milk Code expressly forbid information that would imply or create a
belief that there is any milk product equivalent to breastmilk or which is humanized or
maternalized, as such information would be inconsistent with the superiority of breastfeeding.
It may be argued that Section 8 of the Milk Code refers only to information given to health
workers regarding breastmilk substitutes, not to containers and labels thereof. However, such
restrictive application of Section 8(b) will result in the absurd situation in which milk companies
and distributors are forbidden to claim to health workers that their products are substitutes or
equivalents of breastmilk, and yet be allowed to display on the containers and labels of their
products the exact opposite message. That askewed interpretation of the Milk Code is precisely
what Section 5(a) thereof seeks to avoid by mandating that all information regarding
breastmilk vis-a-vis breastmilk substitutes be consistent, at the same time giving the government
control over planning, provision, design, and dissemination of information on infant feeding.

Thus, Section 26(c) of the RIRR which requires containers and labels to state that the product
offered is not a substitute for breastmilk, is a reasonable means of enforcing Section 8(b) of the
Milk Code and deterring circumvention of the protection and promotion of breastfeeding as
embodied in Section 2[60] of the Milk Code.

Section 26(f)[61] of the RIRR is an equally reasonable labeling requirement. It implements


Section 5(b) of the Milk Code which reads:

SECTION 5. x x x

xxxx

(b) Informational and educational materials, whether written, audio, or visual,


dealing with the feeding of infants and intended to reach pregnant women
and mothers of infants, shall include clear information on all the following
points: x x x (5) where needed, the proper use of infant formula, whether
manufactured industrially or home-prepared. When such materials contain
information about the use of infant formula, they shall include the social
and financial implications of its use; the health hazards of inappropriate
foods or feeding methods; and, in particular, the health hazards of
unnecessary or improper use of infant formula and other breastmilk
substitutes. Such materials shall not use any picture or text which may
idealize the use of breastmilk substitutes. (Emphasis supplied)

The label of a product contains information about said product intended for the buyers
thereof. The buyers of breastmilksubstitutes are mothers of infants, and Section 26 of the RIRR
merely adds a fair warning about the likelihood of pathogenic microorganisms being present in
infant formula and other related products when these are prepared and used inappropriately.

Petitioners counsel has admitted during the hearing on June 19, 2007 that formula milk is prone
to contaminations and there is as yet no technology that allows production of powdered infant
formula that eliminates all forms of contamination.[62]
Ineluctably, the requirement under Section 26(f) of the RIRR for the label to contain the message
regarding health hazards including the possibility of contamination with pathogenic
microorganisms is in accordance with Section 5(b) of the Milk Code.

The authority of DOH to control information regarding breastmilk vis-a-


vis breastmilk substitutes and supplements and related products cannot be questioned. It is its
intervention into the area of advertising, promotion, and marketing that is being assailed by
petitioner.

In furtherance of Section 6(a) of the Milk Code, to wit:

SECTION 6. The General Public and Mothers.

(a) No advertising, promotion or other marketing materials, whether written,


audio or visual, for products within the scope of this Code shall be printed,
published, distributed, exhibited and broadcast unless such materials are duly
authorized and approved by an inter-agency committee created herein pursuant to
the applicable standards provided for in this Code.
the Milk Code invested regulatory authority over advertising, promotional and marketing
materials to an IAC, thus:

SECTION 12. Implementation and Monitoring -

(a) For purposes of Section 6(a) of this Code, an inter-agency committee


composed of the following members is hereby created:

Minister of Health -------------------------------------------- Chairman


Minister of Trade and Industry ---------------------------- Member
Minister of Justice -------------------------------------------- Member
Minister of Social Services and Development ----------- Member

The members may designate their duly authorized representative to every meeting
of the Committee.

The Committee shall have the following powers and functions:

(1) To review and examine all advertising. promotion or other marketing


materials, whether written, audio or visual, on products within the scope
of this Code;

(2) To approve or disapprove, delete objectionable portions from and


prohibit the printing, publication, distribution, exhibition and broadcast of,
all advertising promotion or other marketing materials, whether written,
audio or visual, on products within the scope of this Code;
(3) To prescribe the internal and operational procedure for the exercise of
its powers and functions as well as the performance of its duties and
responsibilities; and

(4) To promulgate such rules and regulations as are necessary or


proper for the implementation of Section 6(a) of this
Code. x x x (Emphasis supplied)

However, Section 11 of the RIRR, to wit:


SECTION 11. Prohibition No advertising, promotions, sponsorships, or
marketing materials and activities for breastmilksubstitutes intended for infants
and young children up to twenty-four (24) months, shall be allowed, because they
tend to convey or give subliminal messages or impressions that
undermine breastmilk and breastfeeding or otherwise
exaggerate breastmilksubstitutes and/or replacements, as well as related products
covered within the scope of this Code.
prohibits advertising, promotions, sponsorships or marketing materials and activities
for breastmilk substitutes in line with the RIRRs declaration of principle under Section 4(f), to
wit:

SECTION 4. Declaration of Principles

xxxx

(f) Advertising, promotions, or sponsorships of infant


formula, breastmilk substitutes and other related products are prohibited.

The DOH, through its co-respondents, evidently arrogated to itself not only the regulatory
authority given to the IAC but also imposed absolute prohibition on advertising, promotion, and
marketing.

Yet, oddly enough, Section 12 of the RIRR reiterated the requirement of the Milk Code in
Section 6 thereof for prior approval by IAC of all advertising, marketing and promotional
materials prior to dissemination.

Even respondents, through the OSG, acknowledged the authority of IAC, and repeatedly insisted,
during the oral arguments on June 19, 2007, that the prohibition under Section 11 is not actually
operational, viz:

SOLICITOR GENERAL DEVANADERA:

xxxx

x x x Now, the crux of the matter that is being questioned by Petitioner is whether
or not there is an absolute prohibition on advertising making AO 2006-12
unconstitutional. We maintained that what AO 2006-12 provides is not an
absolute prohibition because Section 11 while it states and it is entitled prohibition
it states that no advertising, promotion, sponsorship or marketing materials and
activities for breast milk substitutes intended for infants and young children up to
24 months shall be allowed because this is the standard they tend to convey or
give subliminal messages or impression undermine that breastmilk or
breastfeeding x x x.
We have to read Section 11 together with the other Sections because the other
Section, Section 12, provides for the inter agency committee that is empowered to
process and evaluate all the advertising and promotion materials.

xxxx

What AO 2006-12, what it does, it does not prohibit the sale and manufacture, it
simply regulates the advertisement and the promotions of breastfeeding milk
substitutes.
xxxx

Now, the prohibition on advertising, Your Honor, must be taken together with the
provision on the Inter-Agency Committee that processes and evaluates because
there may be some information dissemination that are straight forward
information dissemination. What the AO 2006 is trying to prevent is any material
that will undermine the practice of breastfeeding, Your Honor.

xxxx

ASSOCIATE JUSTICE SANTIAGO:

Madam Solicitor General, under the Milk Code, which body has authority or
power to promulgate Rules and Regulations regarding the Advertising, Promotion
and Marketing of Breastmilk Substitutes?

SOLICITOR GENERAL DEVANADERA:

Your Honor, please, it is provided that the Inter-Agency Committee, Your Honor.

xxxx

ASSOCIATE JUSTICE SANTIAGO:

x x x Don't you think that the Department of Health overstepped its rule making
authority when it totally banned advertising and promotion under Section 11
prescribed the total effect rule as well as the content of materials under Section 13
and 15 of the rules and regulations?

SOLICITOR GENERAL DEVANADERA:

Your Honor, please, first we would like to stress that there is no total absolute
ban. Second, the Inter-Agency Committee is under the Department of Health,
Your Honor.

xxxx
ASSOCIATE JUSTICE NAZARIO:

x x x Did I hear you correctly, Madam Solicitor, that there is no absolute ban on
advertising of breastmilk substitutes in the Revised Rules?

SOLICITOR GENERAL DEVANADERA:

Yes, your Honor.

ASSOCIATE JUSTICE NAZARIO:

But, would you nevertheless agree that there is an absolute ban on advertising
of breastmilk substitutes intended for children two (2) years old and younger?

SOLICITOR GENERAL DEVANADERA:

It's not an absolute ban, Your Honor, because we have the Inter-Agency
Committee that can evaluate some advertising and promotional materials, subject
to the standards that we have stated earlier, which are- they should not undermine
breastfeeding, Your Honor.

xxxx

x x x Section 11, while it is titled Prohibition, it must be taken in relation with the
other Sections, particularly 12 and 13 and 15, Your Honor, because it is
recognized that the Inter-Agency Committee has that power to evaluate
promotional materials, Your Honor.

ASSOCIATE JUSTICE NAZARIO:

So in short, will you please clarify there's no absolute ban on advertisement


regarding milk substitute regarding infants two (2) years below?

SOLICITOR GENERAL DEVANADERA:

We can proudly say that the general rule is that there is a prohibition, however, we
take exceptions and standards have been set.One of which is that, the Inter-
Agency Committee can allow if the advertising and promotions will not
undermine breastmilk and breastfeeding, Your Honor.[63]

Sections 11 and 4(f) of the RIRR are clearly violative of the Milk Code.

However, although it is the IAC which is authorized to promulgate rules and regulations for the
approval or rejection of advertising, promotional, or other marketing materials under Section
12(a) of the Milk Code, said provision must be related to Section 6 thereof which in turn
provides that the rules and regulations must be pursuant to the applicable standards provided for
in this Code. Said standards are set forth in Sections 5(b), 8(b), and 10 of the Code, which, at the
risk of being repetitious, and for easy reference, are quoted hereunder:

SECTION 5. Information and Education

xxxx

(b) Informational and educational materials, whether written, audio, or


visual, dealing with the feeding of infants and intended to reach pregnant
women and mothers of infants, shall include clear information on all the
following points: (1)the benefits and superiority of
breastfeeding; (2) maternal nutrition, and the preparation for and
maintenance of breastfeeding; (3) the negative effect on breastfeeding of
introducing partial bottlefeeding; (4) the difficulty of reversing the
decision not to breastfeed; and (5) where needed, the proper use of infant
formula, whether manufactured industrially or home-prepared. When such
materials contain information about the use of infant formula, they shall
include the social and financial implications of its use; the health hazards
of inappropriate foods of feeding methods; and, in particular, the health
hazards of unnecessary or improper use of infant formula and
other breastmilk substitutes. Such materials shall not use any picture or
text which may idealize the use of breastmilk substitutes.
xxxx

SECTION 8. Health Workers.

xxxx
(b) Information provided by manufacturers and distributors to health
professionals regarding products within the scope of this Code shall be
restricted to scientific and factual matters and such information shall not
imply or create a belief that bottle feeding is equivalent or superior to
breastfeeding. It shall also include the information specified in Section
5(b).

xxxx

SECTION 10. Containers/Label

(a) Containers and/or labels shall be designed to provide the necessary


information about the appropriate use of the products, and in such a way as not to
discourage breastfeeding.
(b) Each container shall have a clear, conspicuous and easily readable and
understandable message in Pilipino or English printed on it, or on a label, which
message can not readily become separated from it, and which shall include the
following points:

(i) the words Important Notice or their equivalent;


(ii) a statement of the superiority of breastfeeding;
(iii) a statement that the product shall be used only on the advice of
a health worker as to the need for its use and the proper methods of
use; and
(iv) instructions for appropriate preparation, and a warning against
the health hazards of inappropriate preparation.
Section 12(b) of the Milk Code designates the DOH as the principal implementing agency for the
enforcement of the provisions of the Code. In relation to such responsibility of the DOH, Section
5(a) of the Milk Code states that:

SECTION 5. Information and Education

(a) The government shall ensure that objective and consistent information
is provided on infant feeding, for use by families and those involved in the
field of infant nutrition. This responsibility shall cover the planning,
provision, design and dissemination of information, and the control
thereof, on infant nutrition. (Emphasis supplied)

Thus, the DOH has the significant responsibility to translate into operational terms the
standards set forth in Sections 5, 8, and 10 of the Milk Code, by which the IAC shall screen
advertising, promotional, or other marketing materials.

It is pursuant to such responsibility that the DOH correctly provided for Section 13 in the RIRR
which reads as follows:

SECTION 13. Total Effect - Promotion of products within the scope of this Code
must be objective and should not equate or make the product appear to be as good
or equal to breastmilk or breastfeeding in the advertising concept. It must not in
any case undermine breastmilk or breastfeeding. The total effect should not
directly or indirectly suggest that buying their product would produce better
individuals, or resulting in greater love, intelligence, ability, harmony or in any
manner bring better health to the baby or other such exaggerated and
unsubstantiated claim.
Such standards bind the IAC in formulating its rules and regulations on advertising, promotion,
and marketing. Through that single provision, the DOH exercises control over the information
content of advertising, promotional and marketing materials on breastmilk vis-a-
vis breastmilk substitutes, supplements and other related products. It also sets a viable standard
against which the IAC may screen such materials before they are made public.

In Equi-Asia Placement, Inc. vs. Department of Foreign Affairs,[64] the Court held:

x x x [T]his Court had, in the past, accepted as sufficient standards the following:
public interest, justice and equity, public convenience and welfare, and simplicity,
economy and welfare.[65]

In this case, correct information as to infant feeding and nutrition is infused with public
interest and welfare.

4. With regard to activities for dissemination of information to health professionals, the


Court also finds that there is no inconsistency between the provisions of the Milk Code and the
RIRR. Section 7(b)[66] of the Milk Code, in relation to Section 8(b)[67] of the same Code, allows
dissemination of information to health professionals but such information is restricted to
scientific and factual matters.

Contrary to petitioner's claim, Section 22 of the RIRR does not prohibit the giving of
information to health professionals on scientific and factual matters. What it prohibits is the
involvement of the manufacturer and distributor of the products covered by the Code in activities
for the promotion, education and production of Information, Education and Communication
(IEC) materials regarding breastfeeding that are intended for women and children. Said
provision cannot be construed to encompass even the dissemination of information to health
professionals, as restricted by the Milk Code.

5. Next, petitioner alleges that Section 8(e)[68] of the Milk Code permits milk
manufacturers and distributors to extend assistance in research and in the continuing education of
health professionals, while Sections 22 and 32 of the RIRR absolutely forbid the same. Petitioner
also assails Section 4(i)[69] of the RIRR prohibiting milk manufacturers' and distributors'
participation in any policymaking body in relation to the advancement of breastfeeding.

Section 4(i) of the RIRR provides that milk companies and their representatives should not form
part of any policymaking body or entity in relation to the advancement of breastfeeding. The
Court finds nothing in said provisions which contravenes the Milk Code. Note that under Section
12(b) of the Milk Code, it is the DOH which shall be principally
responsible for the implementation and enforcement of the provisions of said Code. It is entirely
up to the DOH to decide which entities to call upon or allow to be part of policymaking bodies
on breastfeeding. Therefore, the RIRR's prohibition on milk companies participation in any
policymaking body in relation to the advancement of breastfeeding is in accord with the Milk
Code.

Petitioner is also mistaken in arguing that Section 22 of the RIRR prohibits milk
companies from giving reasearchassistance and continuing education to health
professionals. Section 22[70] of the RIRR does not pertain to research assistance to or the
continuing education of health professionals; rather, it deals with breastfeeding promotion
and education for women and children. Nothing in Section 22 of the RIRR prohibits milk
companies from giving assistance for research or continuing education to health professionals;
hence, petitioner's argument against this particular provision must be struck down.

It is Sections 9[71] and 10[72] of the RIRR which govern research assistance. Said sections
of the RIRR provide that research assistance for health workers and researchers may be
allowed upon approval of an ethics committee, and with certain disclosure requirements
imposed on the milk company and on the recipient of the research award.

The Milk Code endows the DOH with the power to determine how such research or
educational assistance may be given by milk companies or under what conditions health workers
may accept the assistance. Thus, Sections 9 and 10 of the RIRR imposing limitations on the kind
of research done or extent of assistance given by milk companies are completely in accord with
the Milk Code.
Petitioner complains that Section 32[73] of the RIRR prohibits milk companies from
giving assistance, support, logistics or training to health workers. This provision is within the
prerogative given to the DOH under Section 8(e)[74] of the Milk Code, which provides that
manufacturers and distributors of breastmilk substitutes may assist in researches, scholarships
and the continuing education, of health professionals in accordance with the rules and regulations
promulgated by the Ministry of Health, now DOH.

6. As to the RIRR's prohibition on donations, said provisions are also consistent with the
Milk Code. Section 6(f) of the Milk Code provides that donations may be made by
manufacturers and distributors of breastmilk substitutes upon the request or with the approval
of the DOH. The law does not proscribe the refusal of donations. The Milk Code leaves it purely
to the discretion of the DOH whether to request or accept such donations. The DOH then
appropriately exercised its discretion through Section 51[75] of the RIRR which sets forth its
policy not to request or approve donations from manufacturers and distributors
of breastmilk substitutes.
It was within the discretion of the DOH when it provided in Section 52 of the RIRR that
any donation from milk companies not covered by the Code should be coursed through the IAC
which shall determine whether such donation should be accepted or refused. As reasoned out by
respondents, the DOH is not mandated by the Milk Code to accept donations. For that matter, no
person or entity can be forced to accept a donation. There is, therefore, no real inconsistency
between the RIRR and the law because the Milk Code does not prohibit the DOH from refusing
donations.

7. With regard to Section 46 of the RIRR providing for administrative sanctions that are
not found in the Milk Code,the Court upholds petitioner's objection thereto.

Respondent's reliance on Civil Aeronautics Board v. Philippine Air Lines, Inc.[76] is


misplaced. The glaring difference in said case and the present case before the Court is that, in
the Civil Aeronautics Board, the Civil Aeronautics Administration (CAA) was expressly
granted by the law (R.A. No. 776) the power to impose fines and civil penalties, while the
Civil Aeronautics Board (CAB) was granted by the same law the power to review on appeal the
order or decision of the CAA and to determine whether to impose, remit, mitigate, increase or
compromise such fine and civil penalties. Thus, the Court upheld the CAB's Resolution imposing
administrative fines.

In a more recent case, Perez v. LPG Refillers Association of the Philippines, Inc.,[77] the
Court upheld the Department of Energy (DOE) Circular No. 2000-06-10
implementing Batas Pambansa (B.P.) Blg. 33. The circular provided for fines for the
commission of prohibited acts. The Court found that nothing in the circular contravened the law
because the DOE was expressly authorized by B.P. Blg. 33 and R.A. No. 7638 to impose fines or
penalties.

In the present case, neither the Milk Code nor the Revised Administrative Code grants
the DOH the authority to fix or impose administrative fines. Thus, without any express grant of
power to fix or impose such fines, the DOH cannot provide for those fines in the RIRR. In this
regard, the DOH again exceeded its authority by providing for such fines or sanctions in Section
46 of the RIRR. Said provision is, therefore, null and void.

The DOH is not left without any means to enforce its rules and regulations. Section 12(b)
(3) of the Milk Code authorizes the DOH to cause the prosecution of the violators of this Code
and other pertinent laws on products covered by this Code. Section 13 of the Milk Code provides
for the penalties to be imposed on violators of the provision of the Milk Code or the rules and
regulations issued pursuant to it, to wit:

SECTION 13. Sanctions

(a) Any person who violates the provisions of this Code or the rules and
regulations issued pursuant to this Codeshall, upon conviction, be punished by
a penalty of two (2) months to one (1) year imprisonment or a fine of not less than
One Thousand Pesos (P1,000.00) nor more than Thirty Thousand Pesos
(P30,000.00) or both. Should the offense be committed by a juridical person, the
chairman of the Board of Directors, the president, general manager, or the
partners and/or the persons directly responsible therefor, shall be penalized.

(b) Any license, permit or authority issued by any government agency to


any health worker, distributor, manufacturer, or marketing firm or personnel for
the practice of their profession or occupation, or for the pursuit of their business,
may, upon recommendation of the Ministry of Health, be suspended or revoked in
the event of repeated violations of this Code, or of the rules and regulations issued
pursuant to this Code. (Emphasis supplied)

8. Petitioners claim that Section 57 of the RIRR repeals existing laws that are contrary to the
RIRR is frivolous.
Section 57 reads:

SECTION 57. Repealing Clause - All orders, issuances, and rules and regulations
or parts thereof inconsistent with these revised rules and implementing regulations
are hereby repealed or modified accordingly.

Section 57 of the RIRR does not provide for the repeal of laws but only orders, issuances and
rules and regulations. Thus, said provision is valid as it is within the DOH's rule-making power.

An administrative agency like respondent possesses quasi-legislative or rule-making power or


the power to make rules and regulations which results in delegated legislation that is within the
confines of the granting statute and the Constitution, and subject to the doctrine of non-
delegability and separability of powers.[78] Such express grant of rule-
making powernecessarily includes the power to amend, revise, alter, or repeal the same.[79] This
is to allow administrative agencies flexibility in formulating and adjusting the details and manner
by which they are to implement the provisions of a law,[80]in order to make it more responsive to
the times. Hence, it is a standard provision in administrative rules that prior issuances of
administrative agencies that are inconsistent therewith are declared repealed or modified.

In fine, only Sections 4(f), 11 and 46 are ultra vires, beyond the authority of the DOH to
promulgate and in contravention of the Milk Code and, therefore, null and void. The rest of the
provisions of the RIRR are in consonance with the Milk Code.

Lastly, petitioner makes a catch-all allegation that:

x x x [T]he questioned RIRR sought to be implemented by the Respondents


is unnecessary and oppressive, and is offensive to the due process clause of
the Constitution, insofar as the same is in restraint of trade and because a
provision therein is inadequate to provide the public with a comprehensible basis
to determine whether or not they have committed a violation.[81](Emphasis
supplied)
Petitioner refers to Sections 4(f),[82] 4(i),[83] 5(w),[84] 11,[85] 22,[86] 32,[87] 46,[88] and 52[89] as the
provisions that suppress the trade of milk and, thus, violate the due process clause of the
Constitution.

The framers of the constitution were well aware that trade must be subjected to some form of
regulation for the public good. Public interest must be upheld over business interests.[90] In Pest
Management Association of the Philippines v. Fertilizer and Pesticide Authority,[91] it was held
thus:
x x x Furthermore, as held in Association of Philippine Coconut Desiccators v.
Philippine Coconut Authority, despite the fact that our present Constitution
enshrines free enterprise as a policy, it nonetheless reserves to the
government the power to intervene whenever necessary to promote the
general welfare. There can be no question that the unregulated use or
proliferation of pesticides would be hazardous to our environment. Thus, in
the aforecited case, the Court declared that free enterprise does not call for
removal of protective regulations. x x x It must be clearly explained and
proven by competent evidence just exactly how such protective regulation
would result in the restraint of trade. [Emphasis and underscoring supplied]

In this case, petitioner failed to show that the proscription of milk manufacturers participation in
any policymaking body (Section 4(i)), classes and seminars for women and children (Section
22); the giving of assistance, support and logistics or training (Section 32); and the giving of
donations (Section 52) would unreasonably hamper the trade of breastmilksubstitutes. Petitioner
has not established that the proscribed activities are indispensable to the trade
of breastmilksubstitutes. Petitioner failed to demonstrate that the aforementioned provisions of
the RIRR are unreasonable and oppressive for being in restraint of trade.

Petitioner also failed to convince the Court that Section 5(w) of the RIRR is unreasonable and
oppressive. Said section provides for the definition of the term milk company, to wit:

SECTION 5 x x x. (w) Milk Company shall refer to the owner, manufacturer,


distributor of infant formula, follow-up milk, milk formula, milk
supplement, breastmilk substitute or replacement, or by any other description of
such nature, including their representatives who promote or otherwise advance
their commercial interests in marketing those products;
On the other hand, Section 4 of the Milk Code provides:
(d) Distributor means a person, corporation or any other entity in the
public or private sector engaged in the business (whether directly or
indirectly) of marketing at the wholesale or retail level a product
within the scope of this Code. A primary distributor is a
manufacturer's sales agent, representative, national distributor or
broker.

xxxx

(j) Manufacturer means a corporation or other entity in the public or


private sector engaged in the business or function (whether directly or
indirectly or through an agent or and entity controlled by or under
contract with it) of manufacturing a products within the scope of this
Code.

Notably, the definition in the RIRR merely merged together under the term milk company the
entities defined separately under the Milk Code as distributor and manufacturer. The RIRR also
enumerated in Section 5(w) the products manufactured or distributed by an entity that would
qualify it as a milk company, whereas in the Milk Code, what is used is the phrase products
within the scope of this Code. Those are the only differences between the definitions given in
the Milk Code and the definition as re-stated in the RIRR.

Since all the regulatory provisions under the Milk Code apply equally to both manufacturers
and distributors, the Court sees no harm in the RIRR providing for just one term to encompass
both entities. The definition of milk company in the RIRR and the definitions of distributor and
manufacturer provided for under the Milk Code are practically the same.

The Court is not convinced that the definition of milk company provided in the RIRR would
bring about any change in the treatment or regulation of distributors and
manufacturers of breastmilk substitutes, as defined under the Milk Code.
Except Sections 4(f), 11 and 46, the rest of the provisions of the RIRR are in consonance with
the objective, purpose and intent of the Milk Code, constituting reasonable regulation of an
industry which affects public health and welfare and, as such, the rest of the RIRR do not
constitute illegal restraint of trade nor are they violative of the due process clause of the
Constitution.

WHEREFORE, the petition is PARTIALLY GRANTED. Sections 4(f), 11 and 46 of


Administrative Order No. 2006-0012 dated May 12, 2006 are declared NULL and VOID for
being ultra vires. The Department of Health and respondents arePROHIBITED from
implementing said provisions.

The Temporary Restraining Order issued on August 15, 2006 is LIFTED insofar as the rest of
the provisions of Administrative Order No. 2006-0012 is concerned.

SO ORDERED.

MA. ALICIA AUSTRIA-MARTINEZ


Associate Justice

WE CONCUR:

REYNATO S. PUNO
Chief Justice

LEONARDO A. QUISUMBING CONSUELO YNARES-SANTIAGO


Associate Justice Associate Justice

ANGELINA SANDOVAL-GUTIERREZ ANTONIO T. CARPIO


Associate Justice Associate Justice

RENATO C. CORONA CONCHITA CARPIO-MORALES


Associate Justice Associate Justice

ADOLFO S. AZCUNA DANTE O. TINGA


Associate Justice Associate Justice

MINITA V. CHICO-NAZARIO CANCIO C. GARCIA


Associate Justice Associate Justice

PRESBITERO J. VELASCO, JR. ANTONIO EDUARDO B. NACHURA


Associate Justice Associate Justice

RUBEN T. REYES
Associate Justice

CERTIFICATION

Pursuant to Section 13, Article VIII of the Constitution, it is hereby certified that the conclusions
in the above Decision had been reached in consultation before the case was assigned to the writer
of the opinion of the Court.

REYNATO S. PUNO
Chief Justice

[1]
Section 11, Rule 3, 1997 Rules of Civil Procedure which provides:
Section 11. Misjoinder and non-joinder of parties. - Neither misjoinder nor non-joinder of
parties is ground for dismissal of an action. Parties may be dropped or added by order
of the court on motion of any party or on its own initiative at any stage of the
action and on such terms as are just. x x x (Emphasis supplied)
[2]
Article 11. Implementation and monitoring
11.1 Governments should take action to give effect to the principles and aim of this Code,
as appropriate to their social and legislative framework, including the adoption of
national legislation, regulations or other suitable measures. For this purpose, governments
should seek, when necessary, the cooperation of WHO, UNICEF and other agencies of
the United Nations system. National policies and measures, including laws and
regulations, which are adopted to give effect to the principles and aim of this Code should
be publicly stated, and should apply on the same basis to all those involved in the
manufacture and marketing of products within the scope of this Code.
xxxx
[3]
Petition, rollo, p. 12.
[4]
G.R. No. 131719, May 25, 2004, 429 SCRA 81.
[5]
Id. at 96-97.
[6]
G.R. No. 135092, May 4, 2006, 489 SCRA 382.
[7]
Id. at 396.
[8]
Annex G, Petitioner's Memorandum dated July 19, 2007.
[9]
Annexes H, I, and J of Petitioner's Memorandum executed by Wyeth Philippines, Inc., Bristol
Myers Squibb (Phil.), Inc., and Abbott Laboratories, Inc., respectively.
[10]
a) The UN Convention on the Rights of the Child (CRC); b) the International Code of
Marketing Breastmilk Substitutes (ICMBS); c) the International Covenant on
Economic, Social and Cultural Rights (CSCR); d) the Convention on the Elimination
of All Forms of Discrimination Against Women (CEDAW); e) the Global Strategy for
Infant and Young Child Nutrition (Global Strategy); and f) various resolutions adopted
by the World Health Assembly.
[11]
Joaquin G. Bernas, S.J., Constitutional Structure and Powers of Government (Notes
and Cases) Part I ( 2005).
[12]
Id.
[13]
Joaquin G. Bernas, S.J., An Introduction to Public International Law, 2002 Ed., p. 57.
[14]
According to Fr. Bernas, the Austrian Constitution (Art. 9) and the Constitution of the
Federal Republic of Germany (Art. 25) also use the incorporation method.
[15]
G.R. No. 139325, April 12, 2005, 455 SCRA 397.
[16]
Id. at 421.
[17]
Merlin M. Magallona, Fundamentals of Public International Law, 2005 Ed., p. 526.
[18]
Id. at 525.
[19]
Government of Hong Kong Special Administrative Region v. Olalia, G.R. No. 153675, April
19, 2007.
[20]
Taada v. Angara, 338 Phil. 546, 592 (1997).
[21]
Louis Henkin, Richard C. Pugh, Oscar Schachter, Hans Smit, International Law, Cases
and Materials, 2nd Ed., p. 96.
[22]
Supra note 13, at 10-13.
[23]
Minucher v. Court of Appeals, 445 Phil. 250, 269 (2003).
[24]
Article 57. The various specialized agencies, established by intergovernmental agreement and
having wide international responsibilities, as defined in their basic instruments, in
economic, social, cultural, educational, health, and related fields, shall be brought into
relationship with the United Nations in accordance with the provisions of Article 63.
Such agencies thus brought into relationship with the United Nations are hereinafter referred to
as specialized agencies.
[25]
Article 63. The Economic and Social Council may enter into agreements with any of the
agencies referred to in Article 57, defining the terms on which the agency concerned shall be
brought into relationship with the United Nations. Such agreements shall be subject to approval
by the General Assembly.
It may coordinate the activities of the specialized agencies through consultation with
and recommendations to such agencies and through recommendations to the General Assembly
and to the Members of the United Nations.
[26]
Article 18. The functions of the Health Assembly shall be: (a) to determine the policies of
the Organization x x x. (Emphasis supplied)
[27]
Article 21. The Health Assembly shall have authority to adopt regulations
concerning: x x x (e) advertising and labeling of biological, pharmaceutical and
similar products moving in international commerce. (Emphasis supplied)
[28]
Article 23. The Health Assembly shall have authority to make recommendations to
Members with respect to any matter within the competence of the Organization. (Emphasis
supplied)
[29]
See David Fidler, Developments Involving SARS, International Law, and Infectious
Disease Control at the Fifty-Sixth Meeting of the World Health Assembly, June 2003, ASIL.
[30]
In Resolution No. 34.22 (May 21, 1981), the WHA, acting under Article 23 of the
WHO Constitution, adopted the ICBMS.

(a) In Resolution No. 35.26 (May 1982), the WHA urged member states to
implement the ICBMS as a minimum requirement.

(b) In Resolution No. 39.28 (May 16, 1986), the WHA requested the WHO
Director General to direct the attention of member states to the fact that
any food or drink given before complementary feeding is nutritionally
required may interfere with the initiation or maintenance of breastfeeding
and therefore should neither be promoted nor encouraged for us by infants
during this period.

(c) In Resolution No. 43.3 (May 14, 1990), the WHA urged member states
to protect and promote breastfeeding as an essential component of
nutrition policies so as to enable infants to be exclusively breastfed during
the first four to six months of life.

(d) In Resolution No. 45.34 (May 14, 1992), the WHA urged member
states to implement the targets of the Innocenti Declaration specifically, to
give effect to the ICMBS.

(e) In Resolution No. 46.7 (May 10, 1993), the WHA urged member states
to strive to eliminate under-nutrition, malnutrition and nutritional
deficiency among children.

(f) In Resolution No. 47.5 (May 9, 1994), the WHA urged member states
to ensure that there are no donations of supplies of breastmilk substitutes
and other products covered by the ICMBS in any part of the health care
system.

(g) In Resolution No. 49.15 (May 25, 1996), the WHA urged member
states to ensure that complementary foods are not marketed for or used in
ways that undermine exclusive and sustained breastfeeding.

(h) In Resolution No. 54.2 (May 2002), the WHA, noting that despite the
fact that the International Code of Marketing of Breastmilk Substitutes and
relevant subsequent World Health Assembly resolutions state that there
should be no advertising or other forms of promotion of products within its
scope, new modern communication methods including electronic means,
are currently increasingly being used to promote such products; and
conscious of the need for the Codex Alimentarius Commission to take the
International Code and subsequent relevant Health Assembly resolutions
into consideration in dealing with health claims in the development of
food standards and guidelines x x x, urged member states to develop new
approaches to protect, promote and support exclusive breastfeeding for six
months as a global public health recommendation.

(i) In Resolution No. 55.25 (May 15, 2002), the WHA requested the
Codex Alimentarius Commission to ensure that labelling of processed
foods for infants and young children be consistent with the WHO policy
under the ICBMS.

(j) In Resolution No. 58.32 (May 25, 2005), the WHA urged member
states to continue to protect and promote exclusive breastfeeding for six
months.

(k) In Resolution No. 59.21 (May 27, 2006), the WHA reiterated its
support for the Gobal strategy for Infant and Young Child Feeding.
[31]
David Fidler, supra note 29.
[32]
Article 38. 1. The Court, whose function is to decide in accordance with international law
such disputes as are submitted to it, shall apply: a) international conventions, whether general
or particular, establishing rules expressly recognized by the contesting states; b) international
custom, as evidence of a general practice accepted as law;c) the general principles of law
recognized by civilized nations; d) subject to the provisions of Article 59, judicial decisions
and the teachings of the most highly qualified publicists of the various nations, as subsidiary
means for the determination of rules of law.
[33]
Supra note 29.
[34]
Louis Henkin, et al., International Law, Cases and Materials, 2nd Ed., supra note 21, at 114-
136.
[35]
Supra note 19.
[36]
90 Phil. 70 (1951).
[37]
Supra note 15.
[38]
G.R. No. 159938, March 31, 2006, 486 SCRA 405.
[39]
Edward Kwakwa, Some Comments on Rulemaking at the World Intellectual Property
Organization, www.law.duke.edu/shell/cite; September 13, 2007, 12:33, citing the 1999
WIPO Resolution Concerning Provisions on the Protection of Well-Known Marks, 2000
WIPO Recommendation Concerning Trademark Licenses, and 2001 WIPO
Recommendation Concerning Provisions on the Protection of Marks and other Industrial
Property Rights in Signs on the Internet.
[40]
Id.
[41]
Supra note 29.
[42]
Section 2. Purpose These Revised Rules and Regulations are hereby promulgated to ensure
the provision of safe and adequate nutrition for infants and young childrenby the
promotion, protection and support of breastfeeding and by ensuring the proper use
of breastmilk substitutes, breastmilk supplements and related products when these are medically
indicated and only when necessary, on the basis of adequate information and through appropriate
marketing and distribution. (Underscoring supplied)
[43]
Section 5(ff). Young Child means a person from the age of more than twelve (12) months up
to the age of three (3) years (36 months). (Underscoring supplied)
[44]
G.R. No. 144218, July 14, 2006, 495 SCRA 42, 55.
[45]
See pp. 19-21.
[46]
See p. 21.
[47]
Executive Order No. 292, made effective on November 23, 1989 by Proclamation No. 495.
[48]
Jacobson v. Massachusetts, 197 US 11 (1905); Beltran v. Secretary of Health G.R. No.
133640, November 25, 2005, 476 SCRA 168, 196; St. Lukess Medical Center Employees
Association- AFW v. National Labor Relations Commission, G.R. No. 162053, March 7,
2007; Tablarin v. Gutierrez, G.R. No. L-78164, July 31, 1987, 152 SCRA 730, 741; Pollution
Adjudication Board v. Court of Appeals, G.R. No. 93891, March 11, 1991, 195 SCRA 112,
123-124; Rivera v. Campbell, 34 Phil. 348, 353-354 (1916); Lorenzo v. Director of Health, 50
Phil. 595, 597 (1927).
[49]
As early as People v. Pomar, 46 Phil. 440, 445 (1924), we already noted that advancing
civilization is bringing within the scope of police power of the state today things which
were not thought of as being with in such power yesterday. The development of
civilization, the rapidly increasing population, the growth of public opinion, with [an
increasing] desire on the part of the masses and of the government to look after and care
for the interests of the individuals of the state, have brought within the police power of
the state many questions for regulation which formerly were not so considered.
[50]
Act No. 2711, approved on March 10, 1917.
[51]
Known then as Public Health Service
[52]
Section 1, Chapter I, Title IX, Executive Order No. 292.
[53]
Id. at Section 3.
[54]
SECTION 6. The General Public and Mothers
(a) No advertising, promotion or other marketing materials, whether written,
audio or visual, for products within the scope of this Code shall be printed,
published, distributed, exhibited and broadcast unless such materials are duly
authorized and approved by an inter-agency committee created herein
pursuant to the applicable standards provided for in this Code.
(b) Manufacturers and distributors shall not be permitted to give, directly or
indirectly, samples and supplies of products within the scope of this Code or
gifts of any sort to any member of the general public, including members of
their families, to hospitals and other health institutions, as well as to personnel
within the health care system, save as otherwise provided in this Code.
(c) There shall be no point-of-sale advertising, giving of samples or any other
promotion devices to induce sales directly to the consumers at the retail level,
such as special displays, discount coupons, premiums, special sales, bonus and
tie-in sales for the products within the scope of this Code. This provision shall
not restrict the establishment of pricing policies and practices intended to
provide products at lower prices on a long-term basis.
(d) Manufactures and distributors shall not distribute to pregnant women or
mothers of infants any gifts or articles or utensils which may promote the use
of breastmilk substitutes or bottlefeeding, nor shall any other groups,
institutions or individuals distribute such gifts, utensils or products to the
general public and mothers.
(e) Marketing personnel shall be prohibited from advertising or promoting in
any other manner the products covered by this Code, either directly or
indirectly, to pregnant women or with mother of infants, except as otherwise
provided by this Code.
(f) Nothing herein contained shall prevent donations from manufacturers and
distributors or products within the scope of this Code upon request by or with
the approval of the Ministry of Health.
SECTION 7. Health Care System
(a) The Ministry of Health shall take appropriate measures to encourage and
promote breastfeeding. It shall provide objective and consistent information,
training and advice to health workers on infant nutrition, and on their
obligations under this Code.
(b) No facility of the health care system shall be used for the purpose of
promoting infant formula or other products within the scope of this Code. This
Code does not, however, preclude the dissemination of information to health
professionals as provided in Section 8(b).

(c) Facilities of the health care system shall not be used for the display of
products within the scope of this Code, or for placards or posters concerning
such products.
(d) The use by the health care system of professional service
representatives, mothercraft nurses or similar personnel, provided or paid for
by manufacturers or distributors, shall not be permitted.

(e) In health education classes for mothers and the general public, health
workers and community workers shall emphasize the hazards and risks of the
improper use of breastmilk substitutes particularly infant formula. Feeding
with infant formula shall be demonstrated only to mothers who may not be
able to breastfeed for medical or other legitimate reasons.
SECTION 8. Health Workers
(a) Health workers shall encourage and promote breastfeeding and shall make
themselves familiar with objectives and consistent information on maternal
and infant nutrition, and with their responsibilities under this Code.
(b) Information provided by manufacturers and distributors to health
professionals regarding products within the scope of this Code shall be
restricted to scientific and factual matters and such information shall not imply
or create a belief that bottlefeeding is equivalent or superior to
breastfeeding. It shall also include the information specified in Section 5(b).
(c) No financial or material inducements to promote products within the scope
of this Code shall be offered by manufacturers or distributors to health
workers or members of their families, nor shall these be accepted by the health
workers or members of their families, except as otherwise provided in Section
8(e).
(d) Samples of infant formula or other products within the scope of this Code,
or of equipment or utensils for their preparation or use, shall not be provided
to health workers except when necessary for the purpose of professional
evaluation or research in accordance with the rules and regulations
promulgated by the Ministry of Health. No health workers shall give samples
of infant formula to pregnant women and mothers of infants or members of
their families.
(e) Manufacturers and distributors of products within the scope of this Code
may assist in the research, scholarships and continuing education, of health
professionals, in accordance with the rules and regulations promulgated by the
Ministry of Health.
SECTION 9. Persons employed by Manufacturers and Distributors Personnel employed
in marketing products within the scope of this Code shall not, as part of their job
responsibilities, perform educational functions in relation to pregnant women or mothers
of infants.
[55]
See p. 20.
[56]
See p. 21.
[57]
SECTION 16. All health and nutrition claims for products within the scope of the Code
are absolutely prohibited. For this purpose, any phrase or words that connotes to increase
emotional, intellectual abilities of the infant and young child and other like phrases shall not
be allowed.
[58]
See p. 30.
[59]
SECTION 10. Containers/Label
xxxx
(d) The term humanized, maternalized or similar terms shall not be used.
[60]
SECTION 2. Aim of the Code The aim of the Code is to contribute to the provision of safe
and adequate nutrition for infants by the protection and promotion of breastfeeding and by
ensuring the proper use of breastmilk substitutes and breastmilk supplements when these are
necessary, on the basis of adequate information and through appropriate marketing and
distribution.
[61]
SECTION 26. Content Each container/label shall contain such message, in both Filipino
and English languages, and which message cannot be readily separatedtherefrom, relative
the following points:
xxxx
(f) The health hazards of unnecessary or improper use of infant formula and other related
products including information that powdered infant formula may contain pathogenic
microorganisms and must be prepared and used appropriately.
[62]
TSN of the hearing of June 19, 2007, pp. 114-120.
[63]
TSN of June 19, 2007 hearing, pp. 193-194, 198, 231, 237-240, 295-300.
[64]
G.R. No. 152214, September 19, 2006, 502 SCRA 295.
[65]
Id. at 314.
[66]
SECTION 7. Health Care System
xxxx
(b) No facility of the health care system shall be used for the purpose of promoting infant
formula or other products within the scope of this Code. This Code does not, however,
preclude the dissemination of information to health professionals as provided in Section 8(b).
[67]
SECTION 8. Health Workers. -
xxxx
(b) Information provided by manufacturers and distributors to health professionals
regarding products within the scope of this Code shall be restricted to scientific and factual
matters and such information shall not imply or create a belief that bottlefeeding is equivalent
or superior to breastfeeding. It shall also include the information specified in Section 5(b).
[68]
SECTION 8. Health Workers -
xxxx
(e) Manufacturers and distributors of products within the scope of this Code may assist in
the research, scholarships and continuing education, of health professionals, in accordance with
the rules and regulations promulgated by the Ministry of Health.
[69]
SECTION 4. Declaration of Principles The following are the underlying principles from
which the revised rules and regulations are premised upon:
xxxx
(i) Milk companies, and their representatives, should not form part of any policymaking
body or entity in relation to the advancement of breastfeeding.
[70]
SECTION 22. No manufacturer, distributor, or representatives of products covered by the
Code shall be allowed to conduct or be involved in any activity on breastfeeding
promotion, education and production of Information, Education and Communication
(IEC) materials on breastfeeding, holding of or participating as speakers in classes or
seminars for women and children activities and to avoid the use of these venues to market
their brands or company names.
[71]
SECTION 9. Research, Ethics Committee, Purpose - The DOH shall ensure that
research conducted for public policy purposes, relating to infant and young child feeding
should, at all times, be free form any commercial influence/bias; accordingly, the health
worker or researcher involved in such must disclose any actual or potential conflict of interest
with the company/person funding the research. In any event, such research and its findings
shall be subjected to independent peer review. x xx.
[72]
SECTION 10. Public Disclosure For transparency purposes, a disclosure and/or disclaimer
of the sponsoring company should be done by the company itself, health worker, researcher
involved through verbal declaration during the public presentation of the research and in print
upon publication.
[73]
SECTION 32. Primary Responsibility of Health Workers It is the primary responsibility of
the health workers to promote, protect and support breastfeeding and appropriate infant and
young child feeding. Part of this responsibility is to continuously update their knowledge and
skills on breastfeeding. No assistance, support, logistics or training from milk companies shall
be permitted.
[74]
Supra note 68.
[75]
SECTION 51. Donations Within the Scope of This Code - Donations of products,
materials, defined and covered under the Milk Code and these implementing rules and
regulations, shall be strictly prohibited.
[76]
159-A Phil. 142 (1975).
[77]
G.R. No. 159149, June 26, 2006, 492 SCRA 638.
[78]
Smart Communications, Inc. v. National Telecommunications Commission, 456 Phil. 145,
155-156 (2003).
[79]
Yazaki Torres Manufacturing, Inc. v. Court of Appeals, G.R. No. 130584, June 27, 2006,
493 SCRA 86, 97.
[80]
Supra note 78, at 156.
[81]
Petitioner's Memorandum.
[82]
SECTION 4. Declaration of Principles The following are the underlying principles from
which the revised rules and regulations are premised upon:
xxxx
(f) Advertising, promotions, or sponsorships of infant formula, breastmilk substitutes and
other related products are prohibited.
[83]
SECTION 4. Declaration of Principles x x x
(i) Milk companies, and their representatives, should not form part of any policymaking
body or entity in relation to the advancement of breastfeeding.
[84]
SECTION 5. x x x x (w) Milk Company shall refer to the owner, manufacturer, distributor,
of infant formula, follow-up milk, milk formula, milk supplement, breastmilk substitute
or replacement, or by any other description of such nature, including their representatives
who promote or otherwise advance their commercial interests in marketing those products;
x x x.
[85]
SECTION 11. Prohibition No advertising, promotions, sponsorships, or marketing materials
and activities for breastmilk substitutes intended for infants and young children up to twenty-four
(24) months, shall be allowed, because they tend to convey or give subliminal messages or
impressions that undermine breastmilk and breastfeeding or otherwise
exaggerate breastmilk substitutes and/or replacements, as well as related products covered within
the scope of this Code.
[86]
Supra note 70.
[87]
Supra note 73.
[88]
SECTION 46. Administrative Sanctions. The following administrative sanctions shall
be imposed upon any person, juridical or natural, found to have violated the provisions of the
Code and its implementing Rules and Regulations:
a) 1st violation Warning;
b) 2nd violation Administrative fine of a minimum of Ten Thousand (P10,000.00) to Fifty
Thousand (P50,000.00) Pesos, depending on the gravity and extent of the violation,
including the recall of the offending product;
rd
(c) 3 violation Administrative Fine of a minimum of Sixty Thousand (P60,000.00) to One
Hundred Fifty Thousand (P150,000.00) Pesos, depending on the gravity and extent of the
violation, and in addition thereto, the recall of the offending product, and suspension of the
Certificate of Product Registration (CPR);
(d) 4th violation Administrative Fine of a minimum of Two Hundred Thousand (P200,000.00) to
Five Hundred (P500,000.00) Thousand Pesos, depending on the gravity and extent of the
violation; and in addition thereto, the recall of the product, revocation of the CPR,
suspension of the License to Operate (LTO) for one year;
(e) 5th and succeeding repeated violations Administrative Fine of One Million (P1,000,000.00)
Pesos, the recall of the offending product, cancellation of the CPR, revocation of the
License to Operate (LTO) of the company concerned, including the blacklisting of the
company to be furnished the Department of Budget and Management (DBM) and the
Department of Trade and Industry (DTI);
(f) An additional penalty of Two Thou-sand Five Hundred (P2,500.00) Pesos per day shall be
made for every day the violation continues after having received the order from the IAC
or other such appropriate body, notifying and penalizing the company for the infraction.
For purposes of determining whether or not there is repeated violation, each product violation
belonging or owned by a company, including those of their subsidiaries, are deemed to be
violations of the concerned milk company and shall not be based on the specific violating
product alone.
[89]
SECTION 52. Other Donations By Milk Companies Not Covered by this Code - Donations
of products, equipments, and the like, not otherwise falling within the scope of this Code or
these Rules, given by milk companies and their agents, representatives, whether in kind or in
cash, may only be coursed through the Inter Agency Committee (IAC), which shall determine
whether such donation be accepted or otherwise.
[90]
Eastern Assurance & Surety Corporation v. Land Transportation Franchising and
Regulatory Board, 459 Phil. 395, 399 (2003).
[91]
G.R. No. 156041, February 21, 2007.